# K202691: Ortholock Anchorage Devices

- Pathway: 510(k) (Traditional)
- Applicant: Craniofacial Technologies, Inc.
- Decided: Apr 28, 2022 after 590 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063495 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063495: C Type, CT Type, and Special Type Orthodontic Anchor Screws, Biomaterials Korea, Inc. (2007) Summary page 5.

## Indications for use
The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Source page: https://510kreport.com/device/K202691
Methodology: https://510kreport.com/methodology